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deferoxamine mesylate for injection, USP Dosage and Administration

DOSAGE AND ADMINISTRATION

Acute Iron Intoxication

Intramuscular Administration

This route is preferred and should be used for ALL PATIENTS NOT IN SHOCK.

A dose of 1,000 mg should be administered initially. This may be followed by 500 mg every 4 hours for two doses. Depending upon the clinical response, subsequent doses of 500 mg may be administered every 4 to 12 hours. The total amount administered should not exceed 6,000 mg in 24 hours. For reconstitution instructions for intramuscular administration see Table 1.

Intravenous Administration

THIS ROUTE SHOULD BE USED ONLY FOR PATIENTS IN A STATE OF CARDIOVASCULAR COLLAPSE AND THEN ONLY BY SLOW INFUSION. THE RATE OF INFUSION SHOULD NOT EXCEED 15 MG/KG/HR FOR THE FIRST 1,000 MG ADMINISTERED. SUBSEQUENT IV DOSING, IF NEEDED, MUST BE AT A SLOWER RATE, NOT TO EXCEED 125 MG/HR.

For reconstitution instructions for intravenous administration see Table 2. The reconstituted solution is added to physiologic saline, (e.g., 0.9% sodium chloride, 0.45% sodium chloride), glucose in water, or Ringer's lactate solution.

An initial dose of 1,000 mg should be administered at a rate NOT TO EXCEED 15 mg/kg/hr. This may be followed by 500 mg over 4 hours for two doses. Depending upon the clinical response, subsequent doses of 500 mg may be administered over 4 to 12 hours. The total amount administered should not exceed 6,000 mg in 24 hours.

As soon as the clinical condition of the patient permits, intravenous administration should be discontinued and the drug should be administered intramuscularly.

Chronic Iron Overload

Subcutaneous Administration

A daily dose of 1,000 to 2,000 mg (20 to 40 mg/kg/day) should be administered over 8 to 24 hours, utilizing a small portable pump capable of providing continuous mini-infusion. The duration of infusion must be individualized. In some patients, as much iron will be excreted after a short infusion of 8 to 12 hours as with the same dose given over 24 hours. For reconstitution instructions for subcutaneous administration see Table 3.

Intravenous Administration

The standard recommended method of Deferoxamine Mesylate for Injection, USP administration is via slow subcutaneous infusion over 8 to 12 hours. In patients with intravenous access, the daily dose of Deferoxamine Mesylate for Injection, USP can be administered intravenously. The standard dose is 20 to 40 mg/kg/day for children and 40 to 50 mg/kg/day over 8 to 12 hours in adults for 5 to 7 days per week. In children, average doses should not exceed 40 mg/kg/day until growth has ceased. In adults, average doses should not exceed 60 mg/kg/day. The intravenous infusion rate should not exceed 15 mg/kg/hour. For reconstitution instructions for intravenous administration see Table 2.

In patients who are poorly compliant, Deferoxamine Mesylate for Injection, USP may be administered prior to or following same day blood transfusion (for example 1 gram over 4 hours on the day of transfusion); however, the contribution of this mode of administration to iron balance is limited. Deferoxamine Mesylate for Injection, USP should not be administered concurrently with the blood transfusion as this can lead to errors in interpreting side effects such as rash, anaphylaxis and hypotension.

Intramuscular Administration

A daily dose of 500 to 1,000 mg may be administered intramuscularly. The total daily dose should not exceed 1,000 mg. For reconstitution instructions for intramuscular administration see Table 1.

Reconstitution and Preparation

Table 1: Preparation for Intramuscular Administration

RECONSTITUTE DEFEROXAMINE MESYLATE FOR INJECTION, USP WITH
STERILE WATER FOR INJECTION

Vial Size

Amount of Sterile Water for Injection Required for Reconstitution

Total Drug Content after Reconstitution

Final Concentration per mL after Reconstitution

500 mg

2 mL

500 mg/2.35 mL

213 mg/mL

2 grams

8 mL

2 grams/9.4 mL

213 mg/mL

Table 2: Preparation for Intravenous Administration

RECONSTITUTE DEFEROXAMINE MESYLATE FOR INJECTION, USP WITH
STERILE WATER FOR INJECTION

Vial Size

Amount of Sterile Water for Injection Required for Reconstitution

Total Drug Content after Reconstitution

Final Concentration per mL after Reconstitution

500 mg

5 mL

500 mg/5.3 mL

95 mg/mL

2 grams

20 mL

2 grams/21.1 mL

95 mg/mL

Table 3: Preparation for Subcutaneous Administration

RECONSTITUTE DEFEROXAMINE MESYLATE FOR INJECTION, USP WITH
STERILE WATER FOR INJECTION

Vial Size

Amount of Sterile Water for Injection Required for Reconstitution

Total Drug Content after Reconstitution

Final Concentration per mL after Reconstitution

500 mg

5 mL

500 mg/5.3 mL

95 mg/mL

2 grams

20 mL

2 grams/21.1 mL

95 mg/mL

The reconstituted deferoxamine mesylate solution is an isotonic, clear and colorless to slightly-yellowish solution. The drug should be completely dissolved before the solution is withdrawn. Deferoxamine Mesylate for Injection, USP reconstituted with Sterile Water for Injection IS FOR SINGLE-DOSE ONLY. Discard unused portion.

The product should be used immediately after reconstitution (commencement of treatment within 3 hours) for microbiological safety. When reconstitution is carried out under validated aseptic conditions (in a sterile laminar flow hood using aseptic technique), the product may be stored at room temperature for a maximum period of 24 hours before use. Do not refrigerate reconstituted solution. Reconstituting Deferoxamine Mesylate for Injection, USP in solvents or under conditions other than indicated may result in precipitation. Turbid solutions should not be used.

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